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FDA 510(k)

ClearPoint System

K-Number: K222519 · 2022-09-16

ApplicantClearPoint Neuro, Inc.
Decision Date2022-09-16
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ClearPoint System is the device name listed in this FDA 510(k) record. The listed applicant is ClearPoint Neuro, Inc.. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K222519. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearPoint System?

ClearPoint System is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is ClearPoint Neuro, Inc.. The 510(k) number is K222519.

When did ClearPoint System receive FDA 510(k) clearance?

ClearPoint System received FDA 510(k) clearance on 2022-09-16, under 510(k) number K222519.

Who is the listed applicant for ClearPoint System?

The FDA 510(k) record lists ClearPoint Neuro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearPoint System?

The FDA product code for ClearPoint System is HAW.

Other records listing ClearPoint Neuro, Inc. as applicant

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Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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